Extensive-stage Small Cell Lung CancerPhase 3NCT01563601
Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 3 study testing Obatoclax Mesylate, Carboplatine and Etoposide and Carboplatin and Etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Cephalon.
Trial summary
This is a randomized, multi-center, open-label study of approximately 24 months duration (including follow up survival) to evaluate the safety and efficacy of obatoclax mesylate in combination with carboplatin and etoposide versus carboplatin and etoposide alone in chemotherapy-naive patients with extensive-stage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- Obatoclax Mesylate, Carboplatine and Etoposide and Carboplatin and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jan 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has histologic or cytologic confirmation (upon local review) of small cell lung cancer (SCLC).
- The patient has extensive-stage small cell lung cancer (ES-SCLC), as defined by National Comprehensive Cancer Network (NCCN) guidelines.
- The patient has measurable disease as assessed by Response Evaluation Criteria Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
- The patient has not received any prior chemotherapy, biological agent, or investigational drug for SCLC.
- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- The patient is 18 years of age or older at the time informed consent is obtained.
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- The patient must be accessible for study treatment and follow-up. Patients enrolled in this study must be treated at participating study centers for all 3 days of study drug administration in either treatment group.
- The patient has normal organ function.
- Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to study enrollment. Women of childbearing potential and men with partners of childbearing potential must use a highly effective method of contraception throughout the entire study and up to 8 weeks after the last dose of any study drug (including obatoclax maintenance). Effective contraception or birth control is defined as those with a low failure rate (less than 1% per year) when used consistently and correctly.
- Women must not be breastfeeding.
- Written informed consent is obtained.
- Patients with asymptomatic brain metastases may be enrolled and if clinically indicated, may be treated with steroids to be tapered as tolerated by the patient. Patients with symptomatic brain metastases will be eligible for the study after they have received therapeutic whole brain irradiation (WBI), which must be completed at least 7 days before the day of first treatment with study drugs. Since these patients will also be treated with steroids it is recommended that steroids be tapered as clinically indicated and tolerated by the patient. The use of chronic, low-dose steroids is not contraindicated for these patients (or any other patients). Stereotactic radiation will be allowed for 1 to 3 brain metastatic lesions that meet appropriate criteria for that procedure; however, this must be discussed with the study monitor prior to consideration for enrollment into this study.
- The patient must be willing and able to comply with study restrictions and to remain at the study center for the required duration during the study period and willing to return to the study center for the follow-up evaluation as specified in this protocol.
Who cannot join
- The patient has had any prior systemic therapy for ES-SCLC other than radiation therapy or surgery.
- The patient has a history of prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell or squamous cell carcinoma of the skin, or other localized malignancy that has undergone potentially curative therapy and is deemed by his or her treating physician to be at low risk for recurrence for 5 years.
- The patient has a history of hypersensitivity or allergic reactions attributed to components of the obatoclax mesylate formulation (ie, polysorbate 20 and polyethylene glycol [PEG] 300) or to carboplatin or etoposide.
- The patient currently has leptomeningeal disease or paraneoplastic syndromes.
- The patient has uncontrolled intercurrent illness including, but not limited to, symptomatic neurologic illness; active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; clinically significant cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness that would limit compliance with study requirements.
- The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study but will be monitored for safety.)
- The patient has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus (HCV Ab) or a known positive history of antibodies to human immunodeficiency virus (HIV) and is receiving combination antiretroviral therapy.
About this study
Official title: A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer
This is a randomized, multi-center, open-label study of approximately 24 months duration (including follow up survival) to evaluate the safety and efficacy of obatoclax mesylate in combination with carboplatin and etoposide versus carboplatin and etoposide alone in chemotherapy-naive patients with extensive-stage small cell lung cancer.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- Obatoclax Mesylate, Carboplatine and Etoposide, Carboplatin and Etoposide
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obatoclax Mesylate, Carboplatine and EtoposideDrug
Also called Obatoclax: CEP-41601, Carboplatin: Paraplatin, Etoposide: Eposin, Neoposid, Vepesid, Etopophos
Obatoclax Mesylate:
30 mg fixed dose;administered IV on days 1-3 every 21 days for 6 cycles. Maintenance therapy (optional and only if documented CR or PR) with obatoclax mesylate is administered at the same IV dose on days 1-3 every 21 days until disease progression or death.
Carboplatin:
Dose targeted at AUC of 5; administered IV on Day 1 only every 21 days for 6 cycles
Etoposide:
100mg/m2 administered IV on Days 1-3 every 21days for 6 cycles
Carboplatin and EtoposideDrug
Also called Carboplatin: Paraplatin, Etoposide: Eposin, Neoposid, Vepesid, Etopophos
Carboplatin:
Dose targeted at AUC of 5 administered IV on Day 1 only every 21 days for 6 cycles.
Etoposide:
100mg/m2 administered IV on Days 1-3 every 21 days for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Obatoclax mesylate, Carboplatin and Etoposide (CEO) | Experimental | Not described Receives: Drug: Obatoclax Mesylate, Carboplatine and Etoposide |
| Carboplatin and Etoposide (CE) | Active comparator | Not described Receives: Drug: Carboplatin and Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS): Time to Death
After 570 death events have been observed (Interim Analysis after 171 death events)or 24 months from last patient enrolled
Measured: 24 months from last patient enrolled
Secondary outcomes (4)
Progression-Free Survival (PFS)
Randomization to Date of First Documented Disease Progression or Death for up to 24 months from last patient enrolled
Measured: 24 months from last patient enrolled
Duration of Response
First Response to Disease Progression or Death up to 24 months from last patient enrolled
Measured: 24 months from last patient enrolled
Objective Response Rate (Complete Response or Partial Response)
Measured: 37 months
Quality of Life
This is assessed with the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30 and EORTC QLQ-LC13 questionnaires
Measured: 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2016 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563601
- Sponsor's protocol ID
- C41601/3099
- Other IDs
- 2011-005591-41
- Status last verified
- Aug 2012
- First submitted
- 15 Mar 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01563601
- Acronym / sponsor ID
- C41601/3099
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- May 2016 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multi-center, open-label study of approximately 24 months duration (including follow up survival) to evaluate the safety and efficacy of obatoclax mesylate in combination with carboplatin and etoposide versus carboplatin and etoposide alone in chemotherapy-naive patients with extensive-stage small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obatoclax mesylate, Carboplatin and Etoposide (CEO) | Experimental | Drug: Obatoclax Mesylate, Carboplatine and Etoposide |
| Carboplatin and Etoposide (CE) | Active comparator | Drug: Carboplatin and Etoposide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient has histologic or cytologic confirmation (upon local review) of small cell lung cancer (SCLC).
- The patient has extensive-stage small cell lung cancer (ES-SCLC), as defined by National Comprehensive Cancer Network (NCCN) guidelines.
- The patient has measurable disease as assessed by Response Evaluation Criteria Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
- The patient has not received any prior chemotherapy, biological agent, or investigational drug for SCLC.
- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (7 listed)
- The patient has had any prior systemic therapy for ES-SCLC other than radiation therapy or surgery.
- The patient has a history of prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell or squamous cell carcinoma of the skin, or other localized malignancy that has undergone potentially curative therapy and is deemed by his or her treating physician to be at low risk for recurrence for 5 years.
- The patient has a history of hypersensitivity or allergic reactions attributed to components of the obatoclax mesylate formulation (ie, polysorbate 20 and polyethylene glycol [PEG] 300) or to carboplatin or etoposide.
- The patient currently has leptomeningeal disease or paraneoplastic syndromes.
- The patient has uncontrolled intercurrent illness including, but not limited to, symptomatic neurologic illness; active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; clinically significant cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obatoclax Mesylate, Carboplatine and EtoposideAlso: Obatoclax: CEP-41601, Carboplatin: Paraplatin, Etoposide: Eposin, Neoposid, Vepesid, EtopophosObatoclax Mesylate: 30 mg fixed dose;administered IV on days 1-3 every 21 days for 6 cycles. Maintenance therapy (optional and only if documented CR or PR) with obatoclax mesylate is administered at the same IV dose on days 1-3 every 21 days until disease progression or death. Carboplatin: Dose targeted at AUC of 5; administered IV on Day 1 only every 21 days for 6 cycles Etoposide: 100mg/m2 administered IV on Days 1-3 every 21days for 6 cycles | Drug | Obatoclax mesylate, Carboplatin and Etoposide (CEO) |
| Carboplatin and EtoposideAlso: Carboplatin: Paraplatin, Etoposide: Eposin, Neoposid, Vepesid, EtopophosCarboplatin: Dose targeted at AUC of 5 administered IV on Day 1 only every 21 days for 6 cycles. Etoposide: 100mg/m2 administered IV on Days 1-3 every 21 days for 6 cycles | Drug | Carboplatin and Etoposide (CE) |
Primary outcome
Overall survival (OS): Time to Death
Time frame: 24 months from last patient enrolled
After 570 death events have been observed (Interim Analysis after 171 death events)or 24 months from last patient enrolled
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 24 months from last patient enrolled
Duration of Response
Time frame: 24 months from last patient enrolled
Objective Response Rate (Complete Response or Partial Response)
Time frame: 37 months
Quality of Life
Time frame: 37 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Obatoclax Mesylate, Carboplatine and Etoposide and Carboplatin and Etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Cephalon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS): Time to Death (time frame: 24 months from last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.